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Regulatory Affairs Specialist

2 months ago

Durban, KwaZulu-Natal, South Africa SHARON NUROCK RECRUITMENT CC Full time
Job Title: Regulatory Affairs Pharmacist

At Sharon Nurock Recruitment CC, we are seeking a highly skilled Regulatory Affairs Pharmacist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and ensuring the smooth launch of new products.

Key Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with national and international regulations.
  • Prepare and submit regulatory documents, including dossiers and new drug applications.
  • Collaborate with cross-functional teams to ensure regulatory requirements are met.
  • Stay up-to-date with changes in regulatory requirements and ensure the company is compliant.
Requirements:
  • Bachelor's Degree in Pharmacy (non-neg).
  • Medicines registration and CTD/e-CTD training.
  • Min. 3 years' experience in the SA pharmaceutical industry in a manufacturing/quality assurance/regulatory environment.
  • Understanding of a pharmaceutical quality system, cGMP, GPP principles and pharmaceutical legal requirements.
Preferred Qualifications:
  • Regulatory experience and skills in compiling, preparing, submitting and maintaining dossiers and new drug applications.
  • International regulatory submissions.
  • Experience in biological medicines manufacturing industry.
  • e-CTD submissions.
Competencies:
  • MS Office (Word, Excel, PowerPoint, Outlook).
  • SAP proficient.